FDA Warning Letter: Major CGMP Violations and Required Remediation The FDA warning letter identifies significant violations of Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceuticals. The FDA determined that the firm’s methods, facilities, and controls for manufacturing, processing, packing, or holding drugs did not conform to CGMP requirements under 21 CFR Parts 210 and … Read more
FDA Warning Letter: Major Sterility, CAPA, Environmental Monitoring and CGMP Violations The FDA Warning Letter reviewed in this article identifies significant Current Good Manufacturing Practice (CGMP) deficiencies at a pharmaceutical facility involved in the manufacture of sterile injectable drug products. The inspection was conducted under the authority of the U.S. Food and Drug Administration (FDA) … Read more
FDA Warning Letter: Major CGMP Violations in Raw Material Testing, Stability, Validation and Quality Systems This FDA Warning Letter highlights significant violations of Current Good Manufacturing Practice (CGMP) requirements identified during an FDA inspection of a pharmaceutical manufacturing facility. The inspection found deficiencies involving raw material and API identity testing, supplier qualification, stability testing, Quality … Read more
Quality Risk Assessment – New Product Introduction: Non-Sterile Soft Gelatin Capsules Objective: Identify, assess, and control quality risks before commercial manufacture of a new soft gelatin capsule product. 1. Formulation Risks API–excipient incompatibility API degradation / oxidation / hydrolysis Fill viscosity and uniformity Solubility and precipitation Over/under-fill risk 2. Gelatin Shell Risks Gelatin–fill interaction Shell thickness … Read more
Quality Risk Assessment for Solid Oral Dosage Forms for New Product Introduction OBJECTIVEEvaluate and control quality risks before introducing a new oral liquid product to ensure patient safety, product quality, process robustness, and GMP compliance. KEY RISK AREAS 1️⃣ Product & Formulation API–excipient compatibility Solubility / suspension characteristics CQAs: assay, pH, viscosity, microbial limits Preservative … Read more
Quality Risk Assessment for Solid Oral Dosage Forms Non-Sterile Solid Oral Dosage Forms 🎯 OBJECTIVEEvaluate and control quality risks before introducing a new solid oral dosage product to ensure patient safety, product quality, GMP compliance, and process robustness. 🔍 KEY RISK AREAS 1️⃣ Product & Formulation API/excipient compatibility CQAs: assay, dissolution, content uniformity, impurities API … Read more
Quality Risk Management for New Products, Processes, Equipment, Facilities, Technology Transfer and Scale-Up Introducing a new pharmaceutical product, manufacturing process, equipment, facility modification, technology transfer, scale-up activity, or process change can create significant quality risks. A change that appears technically simple may affect: Critical Quality Attributes (CQAs) Critical Process Parameters (CPPs) Material attributes Process capability … Read more